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Evaluation of rapid diagnostic tests: visceral leishmaniasis

Nature Reviews Microbiology volume 5, pages S31–S39 (2007)Cite this article

Visceral leishmaniasis (VL) is a severe infectious disease caused by a protozoan parasite: Leishmania donovani in East Africa and the Indian subcontinent and Leishmania infantum in Latin America and the Mediterranean basin. Not all leishmanial infections lead to overt clinical disease, but in those infected persons who do develop the disease, multiplication of the parasite in the reticulo-endothelial system causes prolonged fever, anaemia, hepatosplenomegaly and weight loss. VL is fatal if it is not adequately treated. The drugs currently used to treat VL can have severe side effects and the clinical presentation of VL is not sufficiently specific to guide treatment. Highly accurate (both sensitive and specific), cheap and simple rapid diagnostic tests (RDTs) are therefore crucial for case-management of VL. Early case detection followed by adequate treatment is also central to control of VL because, as yet, no vaccine is available and the long-term impact of vector control is unclear.

Although the need for accurate VL diagnostics is obvious, innovation in this field has been slow. Since the 1980s, the main objective of VL diagnostics development has been to replace the direct demonstration of parasites in tissue smears, a technique that is invasive and requires considerable expertise, by a 'field test' that is more appropriate for use in a VL-endemic context. Several serological tests have been developed, but none are specific for VL disease as such, although they have proved useful in combination with a clinical case definition.

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Acknowledgements

We would like to acknowledge the participants of the leishmaniasis working group at the Third Annual Meeting of the Diagnostics Evaluations Expert Committee who provided input to Table 2, especially A. Herring, N. Dendukuri and D. Kioy. We also gratefully acknowledge comments on the manuscript by H. Ghalib.

Author information

Authors and Affiliations

  1. Marleen Boelaert is at the Institute of Tropical Medicine, Nationalestraat 155, 2000 Antwerp, Belgium.,

    Marleen Boelaert

  2. Sujit Bhattacharya is at the Indian Council of Medical Research, Ansari Nagar, New Delhi 110029, India.,

    Sujit Bhattacharya

  3. François Chappuis is at the Hôpital Universitaire de Genève, 24 rue Micheli-du-Crest, CH-1211, Geneva 14, Switzerland.,

    François Chappuis

  4. Sayda H. El Safi is at the Faculty of Medical Laboratory Sciences, PO Box 102, Khartoum University, Khartoum, Sudan,

    Sayda H. El Safi

  5. Asrat Hailu is at the Faculty of Medicine, Addis Ababa University, Black Lion Hospital, PO Box 9086, Addis Ababa, Ethiopia.,

    Asrat Hailu

  6. Dinesh Mondal is at LSD, ICDDRB, Mohakhali, Dhaka 1212, Bangladesh.,

    Dinesh Mondal

  7. Suman Rijal is at the B.P. Koirala Institute of Health Sciences, Dharan, Nepal.,

    Suman Rijal

  8. Shyam Sundar is at the Institute of Medical Sciences, Banaras Hindu University, Varanasi 221 005, India.,

    Shyam Sundar

  9. Monique Wasunna is at the Centre for Clinical Research (CCR), Kenya Medical Research Institute (KEMRI), PO Box 20778, 00202 Nairobi, Kenya,

    Monique Wasunna

  10. Rosanna W. Peeling is at the UNICEF/UNDP/World Bank/ WHO Special Programme for Research and Training in Tropical Diseases (TDR), World Health Organization, 20 Avenue Appia, CH-1211 Geneva 27, Switzerland.,

    Rosanna W. Peeling

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Correspondence to Marleen Boelaert or Rosanna W. Peeling.

Supplementary information

Appendix 1

Sample clinic data collection form for the evaluation of VL RDTs (PDF 112 kb)

Appendix 2

Sample informed consent form (PDF 113 kb)

Appendix 3

Sample HIV information and consent form (PDF 121 kb)

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Boelaert, M., Bhattacharya, S., Chappuis, F. et al. Evaluation of rapid diagnostic tests: visceral leishmaniasis. Nat Rev Microbiol 5 (Suppl 11), S31–S39 (2007). https://doi.org/10.1038/nrmicro1766

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